Use of sublingual dexmedetomidine for the treatment of agitation
Inventors
Nandabalan, Krishnan • Yocca, Frank • Sharma, Sameer • NEGI, Harsh • Saini, Deepa
Assignees
EZ Bioxcel Solutions Pvt Ltd • Bioxcel Therapeutics Inc • Bioxcel LLC
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Publication Number
US-11839604-B2
Publication Date
2023-12-12
Expiration Date
Abstract
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Core Innovation
The invention relates to methods of treating agitation in an agitated subject having bipolar disorder. The method includes administering dexmedetomidine or a pharmaceutically acceptable salt thereof to the oral mucosa as one or two single dosage administrations in a solid, water-soluble dosage form that is a film.
The method is configured to provide an anti-agitation effect in less than about 60 minutes after administration without also causing significant sedation after the administration. The agitation treated is not perioperative agitation, and the invention focuses on rapid anti-agitation onset following oral mucosa administration.
Claims Coverage
The partial content includes one independent claim with multiple dependent claims that refine the agitation subtype and administration details. The core coverage centers on rapid anti-agitation after oral mucosa administration of dexmedetomidine or a pharmaceutically acceptable salt while avoiding significant sedation, using a solid water-soluble film dosage form.
Treating agitation with oral mucosa dexmedetomidine without significant sedation
Administering to the oral mucosa of an agitated subject having bipolar disorder one or two single dosage administrations of dexmedetomidine or a pharmaceutically acceptable salt thereof, where the dexmedetomidine or pharmaceutically acceptable salt produces an anti-agitation effect in less than about 60 minutes after administration without also causing significant sedation after the administration.
Not perioperative agitation treatment
Treating agitation wherein the agitation is not perioperative agitation.
Solid water-soluble film dosage form
Administering the dexmedetomidine or pharmaceutically acceptable salt in a solid, water-soluble dosage form, wherein the dosage form is a film.
Acute agitation subtype
Characterizing the agitation as acute agitation.
Chronic agitation subtype
Characterizing the agitation as chronic agitation.
Severe agitation subtype
Characterizing the agitation as severe agitation.
Sublingual administration
Administering dexmedetomidine or a pharmaceutically acceptable salt thereof sublingually.
Dexmedetomidine hydrochloride salt form
Using dexmedetomidine hydrochloride as the pharmaceutically acceptable salt form.
Overall claim coverage requires an agitated subject with bipolar disorder, oral mucosa dosing of dexmedetomidine or a pharmaceutically acceptable salt as one or two single doses, rapid anti-agitation in less than about 60 minutes without significant sedation, exclusion of perioperative agitation, and administration in a solid water-soluble film dosage form. Dependent claims further limit the agitation to acute, chronic, or severe subtypes and refine the administration to sublingual dosing and/or specify dexmedetomidine hydrochloride.
Stated Advantages
Produces an anti-agitation effect in less than about 60 minutes after administration.
Does not also cause significant sedation after administration.
Provides treatment for agitation that is not perioperative agitation.
Documented Applications
Treating agitation in an agitated subject having bipolar disorder (not perioperative agitation).
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